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Non-small Cell Lung Cancer (NSCLC)Phase 2BLOSSOMNCT04563871

Efficacy and Safety of 80mg Osimertinib in Patients With Non-small Cell Lung Cancer(NSCLC)

A Phase 2 study testing 80mg Osimertinib in people with Non-small Cell Lung Cancer (NSCLC), run by Sehhoon Park at 6 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This will be a Phase II, open-label, single-arm, multicenter study of the efficacy and safety of osimertinib (80 mg orally once daily) in patients with LM associated with EGFRm+ NSCLC. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Non-small Cell Lung Cancer (NSCLC)
What is being tested?
80mg Osimertinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
6 sitesSouth Korea
Study dates
17 Nov 2020to 25 Oct 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses.
  • Male and female patients must be at least 18 years of age.
  • Patients must have documented (only allowed for EGFRm+ [exon 19 deletions or L858R] in pre-treated patients) and/or confirmed central/local test result showing eligible EGFR mutation status as specified below:
  • EGFR TKI pre-treated patients: EGFRm+ (exon 19 deletions or L858R), along with valid T790M mutation status
  • All patients will be required to have NSCLC associated with at least 1 site of LM as identified by the Investigator that can be assessed by MRI scan and that is suitable for repeat assessments. Measurable INC or EXC disease by RECIST 1.1 is not required. Concomitant brain metastases and brain metastases previously treated with radiation therapy are allowed. In addition, asymptomatic untreated BM is also allowed.
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  • EGFR TKI pre-treated patients must have had at least 1 prior EGFR TKI (eg, gefitinib, erlotinib, icotinib, dacomitinib or afatinib) and may have had other lines of therapy
  • If the patients is T790M negative, EXC must be stable following previous EGFR TKI treatment. EXC progression is allowed if patients are T790M positive patients
  • ECOG/WHO performance status 0 to 2 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
  • Females must be using highly effective contraceptive measures and must have a negative pregnancy test prior to start of dosing if of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:
  • Post-menopausal, defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
  • Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
  • Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation Further information is in Appendix I (Definition of women of childbearing potential and acceptable contraceptive methods).
  • Male patients must be willing to use barrier contraception
  • For inclusion in the optional genetics research study, patients must provide informed consent for genetic research.
  • If a patient declines to participate in any voluntary exploratory research of the study, there will be no penalty or loss of benefit to the patient and he/she will not be excluded from other aspects of the study.

Who cannot join

  • EGFR TKI pre-treated patients whose T790M mutation status cannot be determined.
  • EGFR TKI pre-treated patients with progressing EXC disease who are T790M mutation-negative. Progressing EXC disease is defined as RECIST 1.1 PD no more than 3 months prior to enrollment, per Investigator assessment.
  • Past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
  • Significant medical or psychiatric illness that would interfere with compliance and ability to tolerate treatment as outlined in the protocol.
  • Any of the following cardiac criteria:
  • Mean resting corrected QTc >470 msec, obtained from ECGs, using the screening clinic ECG machine-derived QTc value
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  • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block, and second degree heart block)
  • Patients with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as the following electrolyte abnormalities, heart failure, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes (TdP):
  • Hypokalemia (serum potassium <3.5 mmol/L)
  • Hypomagnesemia (serum magnesium <0.7 mmol/L)
  • Hypocalcemia (corrected serum calcium <2.1 mmol/L)
  • Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
  • Absolute neutrophil count <1.5×109/L
  • Platelet count <100×109/L
  • Hemoglobin <90 g/L
  • Alanine aminotransferase (ALT) >2.5× the upper limit of normal (ULN) if no demonstrable liver metastases or >5× ULN in the presence of liver metastases
  • Aspartate aminotransferase (AST) >2.5× ULN if no demonstrable liver metastases or >5× ULN in the presence of liver metastases
  • Total bilirubin (TBL) >1.5× ULN if no liver metastases or >3× ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases
  • Creatinine >1.5× ULN concurrent with creatinine clearance <50 mL/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is >1.5× ULN
  • Known INC hemorrhage that is unrelated to tumor.
  • Patients with the clinical manifestation of nervous system failure including severe encephalopathy or with severe nervous system injury related with treatment, such as chemical meningitis.
  • Non-malignant neurological disease that would interfere with evaluation of symptoms or signs of LM.
  • CNS complications that require urgent neurosurgical intervention (eg, resection or shunt placement) up to 2 weeks before to start of IP or patients who have not recovered from side effects of such intervention.
  • Treatment with any of the following:
  • Any cytotoxic chemotherapy, investigational agents, or anticancer drugs (other than EGFR TKI) for the treatment of advanced NSCLC from a previous treatment regimen or clinical study up to 14 days before the first dose of IP.
  • Treatment with an EGFR TKI (eg, afatinib, erlotinib, icotinib, dacomitinib or gefitinib) up to 8 days or approximately 5× half-life, whichever is the longer, before the first dose of IP (if sufficient wash-out time has not occurred due to schedule or PK properties, an alternative appropriate wash-out time based on known duration and time to reversibility of drug-related AEs could be agreed upon by principal investigator).
  • Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP) 3A4 (at least 3 weeks prior) (see Appendix H). All patients must try to avoid concomitant use of any medications, herbal supplements, and/or ingestion of foods with known inducer effects on CYP3A4.
  • Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 prior platinum-therapy related neuropathy.
  • Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the Investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib.
  • Major surgery (excluding placement of vascular access) up to 4 weeks before the first dose of IP.
  • Radiotherapy, as specified, during the following windows:
  • Radiotherapy with a wide field of radiation (including whole brain radiotherapy) up to 2 weeks before the first dose of IP
  • Radiotherapy with a limited field of radiation for palliation up to 1 week before the first dose of IP except for patients receiving radiation to more than 30% of the bone marrow, which must be completed up to 2 weeks before the first dose of IP.
  • Patients receiving intrathecal chemotherapy up to 2 weeks before the first dose of IP.
  • Previously treated with osimertinib.
  • Any requirement for concurrent therapy including radiotherapy for LM other than the specified treatment in this study.
  • Use of corticosteroid to control increased intracranial pressure is allowed
  • History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.
  • Patient with involvement in the planning and/or conduct of the study (applies to both principal investigator and/or staff at the study site).
  • Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
  • Patient has previously participated in the present study, except for rescreened patients with T790M mutation-negative disease who were previously screened but were excluded due to progressing EXC disease that has subsequently been stabilized.
  • For female patients only - Women who are breastfeeding or currently pregnant (confirmed with positive pregnancy test).
  • Contraindication to MRI, including, but not limited to, claustrophobia, pacemakers, metal implants, INC surgical clips, and metal foreign bodies.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

South Korea6 sites

  • ChungBuk National University Hospital

    Cheonju

  • National Cancer Center

    Goyang

  • Seoul National University Bundang Hospital

    Seongnam

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Phase II, Open-label, Single-arm, Multicenter, Efficacy and Safety of 80mg Osimertinib in Patients With Leptomeningeal Metastases(LM) Associated With EGFR Mutation-positive Non-small Cell Lung Cancer(NSCLC)

This will be a Phase II, open-label, single-arm, multicenter study of the efficacy and safety of osimertinib (80 mg orally once daily) in patients with LM associated with EGFRm+ NSCLC.

Read the detailed description

The study will be conducted in approximately 5 sites across South Korea and will include EGFR TKI pre-treated patients. All patients will be required to have NSCLC associated with at least 1 site of LM as identified by the Investigator that can be assessed by magnetic resonance imaging (MRI) scan and that is suitable for repeat assessments. Presence of Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) measurable intracranial (INC) metastases (ie, brain parenchyma and cranial leptomeninges) and/or extracranial (EXC) metastases is not mandatory. The presence of LM will be based on the Investigator assessment of the brain MRI scan. LM will be confirmed by radiologist from the central site to ensure that patients enrolled in the study are assessable for LM radiologically. Patients negative for LM according to radiologist assessment but enrolled in the study will be replaced. The replaced patient will be included in the study and will receive investigational product (IP) if, in the opinion of the Investigator, the patient is able to receive clinical benefit. Such a patient will not be evaluable for LM response in the LM-EFR analysis set.Full analyses set (FAS) is defined as patients enrolled who received at least 1 dose of study treatment. In addition to Response Assessment in Neuro-Oncology criteria for Leptomeningeal Metastases (RANO-LM) assessments, separate RECIST 1.1 imaging assessments on EXC disease and INC (both LM and non-LM) disease will be performed on images acquired using the preferred method of contrast-enhanced computed tomography (CT) scan of the chest and abdomen (and pelvis when indicated) (EXC) and gadolinium contrast-enhanced MRI scan of the brain (INC).

Baseline scans will be acquired within 28 days prior to first dose of IP and then every 8 weeks (±1 week) and every 12 weeks (±1 week) after 12 months relative to first dose. Patients who discontinue IP for reasons other than objective disease progression in all of INC, EXC, and LM, will continue scans every 8 weeks (±1 week; relative to date of first dose of IP) and every 12 weeks (±1 week, after 12 months) until objective progression in INC, EXC, and LM or withdrawal of consent. Progression refers to progression assessed objectively by imaging using RECIST 1.1 for non-LM INC and EXC or RANO-LM criteria as appropriate. If a patient has been deemed to have LM subjective disease progression according to radiological and clinical assessment by the Investigatorstudy treatment can be continue, and the patient should maintain tumor imaging assessments according to the schedule of assessments.

CSF sampling for cytology is not mandatory, but is strongly encouraged, in patients who are willing to have lumbar punctures during the study, or in those patients who have Ommaya reservoirs.

Physical examination, Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status score, vital signs, and laboratory tests (hematology, clinical chemistry, and urinalysis) will be conducted at each visit. Adverse events (AEs) will be monitored and recorded on an ongoing basis. Twelve-lead electrocardiograms (ECGs) will be performed at baseline and at the time point of investigator's decision and will include measurement of the QT interval. A multigated acquisition scan (MUGA) or echocardiogram will be performed at baseline and at the time point of investigator's decision for left ventricular ejection fraction (LVEF) measurement. Plasma and CSF (if feasible) samples for pharmacokinetic (PK) analysis will be collected at pre-dose on Cycle 3 Day 1 and Cycle 6 Day 1.

Patient-Reported Outcome (PRO) questionnaires, including European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 items (EORTC QLQ-C30), EORTC Quality of Life Questionnaire-Brain Cancer Module 20 items (EORTC QLQ-BN20) will be collected at baseline (prior to first dose of IP and prior to all other assessments on Cycle 1 Day 1) and at home (every 8 weeks [±3 days for EORTC QLQ-C30 and EORTC QLQ-BN20 relative to administration of IP). The patient is asked to report PROs up to the end of Cycle 8 or to IP discontinuation, whichever comes first.

Being tested
80mg Osimertinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 80mg OsimertinibDrug

    Also called Tagrisso 80mg

    One tablet of 80mg Osimertinib for oral administration per day

Study groups in NCT04563871
Study groupRoleWhat they receive
80mg OsimertinibExperimentalOne tablet of 80mg Osimertinib for oral administration per day
Receives: Drug: 80mg Osimertinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    To investigate the efficacy of osimertinib on LM as measured by OS

    Measured: Up to 30 months

Secondary outcomes (5)

  1. LM ORR(Objective response rate)

    BICR(Blinded independent central review) assessments, based on neuroimaging RANO-LM

    Measured: Up to 30 months

  2. LM DoR(Duration of response)

    BICR(Blinded independent central review) assessments, based on neuroimaging RANO-LM

    Measured: Up to 30 months

  3. LM DCR(Disease control rate)

    BICR(Blinded independent central review) assessments, based on neuroimaging RANO-LM

    Measured: Up to 30 months

  4. LM PFS(Progression-free survival)

    BICR(Blinded independent central review) assessments, based on neuroimaging RANO-LM

    Measured: Up to 30 months

  5. CSF response rate based on CSF cytology

    To investigate the efficacy of osimertinib in patients with LM associated with EGFRm+ NSCLC on the CSF cytological clearance

    Measured: Up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2020
  2. Study start17 Nov 2020
  3. Primary completion25 Oct 2023
  4. Study completion25 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
80 mg Osimertinib
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04563871
Sponsor's protocol ID
2020-09-013
Acronym
BLOSSOM
Status last verified
Jan 2026
First submitted
14 Sep 2020
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Park S, Baldry R, Jung HA, Sun JM, Lee SH, Ahn JS, Kim YJ, Lee Y, Kim DW, Kim SW, Lee KH, Lee WJ, Choi JW, Chong K, Lee JI, Gwon SH, Son NH, Ahn MJ. Phase II Efficacy and Safety of 80 mg Osimertinib in Patients With Leptomeningeal Metastases Associated With Epidermal Growth Factor Receptor Mutation-Positive Non-Small Cell Lung Cancer (BLOSSOM). J Clin Oncol. 2024 Aug 10;42(23):2747-2756. doi: 10.1200/JCO.24.00708. Epub 2024 Jun 3.

    PubMed 38828959

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 80mg Osimertinib in people with Non-small Cell Lung Cancer (NSCLC), run by Sehhoon Park at 6 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Up to 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04563871, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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